On 10 April 2019 the Australian Government released amendments to the Gene Technology Regulations 2001 (Cth) (Regulations) which will change the law in Australia so that organisms (including plants, animals and human cell lines) developed using certain types of new gene editing techniques will no longer be classified and regulated as genetically modified organisms (GMOs) under the Gene Technology Act 2000 (Act).
The amendments will have wide ranging benefits for agricultural research in Australia, allowing animal and plant breeders to utilise new available gene editing technology to develop and bring to market improved varieties at a quicker pace and at a lower cost than traditional breeding methods.
Although the use of gene editing techniques to solve human health problems is not nearly as close to commercialisation as in agriculture, the amendments open up new opportunities in the medicinal research space, giving health and medical researchers confidence that they are meeting regulatory requirements in their research and application.
GMOs and regulation of GMOs under the current legislative framework
The amendments follow a 12 month technical review of the Regulations and a two year consultation conducted by the Gene Technology Regulator (Regulator), resolving a debated and contentious uncertainty in the legislation as to whether organisms modified using certain new technologies meet the definition of GMO under the Act.
The purpose of the amendments is to bring the regulatory regime up to date with advancements in technology used to modify organisms and current scientific understanding of the risks they pose.
The Act establishes a scheme for regulating dealings with GMOs in Australia to protect the health and safety of people and the environment.
If an organism meets the definition of GMO under the Act then defined dealings with that organism will be regulated by the Act, which includes receiving approval from the Regulator before intentional environmental release. The Regulator will only grant a licence for dealings involving environmental release if satisfied that any risks posed can be managed so as to protect human health and safety and the environment.
GMO is broadly defined under the Act as an organism that has been modified by gene technology unless the organism is declared by the Regulations not to be a GMO or to belong to a class of organisms that are not GMOs.
Schedule 1 of the Regulations lists those organisms that are not GMOs (Excluded Organisms). Specifically, Item 1 of Schedule 1 lists "a mutant organism in which the mutational event did not involve the introduction of any foreign nucleic acid (that is, non-homologous DNA, usually from another species)" as not being a GMO. With developments in technology since the list of Excluded Organisms was drafted in 2001, Item 1 has become ambiguous, and it is unclear whether new gene editing technologies where new DNA is not inserted into the organism fall within the scope of Excluded Organisms.
GMOs under the amendments
The amendments provide clarity on how organisms modified using new gene editing technologies are regulated.
- amend Schedule 1 to include "an organism modified by repair of single strand or double strand breaks of genomic DNA induced by a site directed nuclease, if a nucleic acid template was not added to guide homology directed repair" as an Excluded Organism; and
- insert a new Schedule 1B to clarify that organisms modified using the following gene editing techniques will be considered GMOs:
- oligonucleotide directed mutagenesis; and
- repair of single strand or double strand breaks of genomic DNA induced by a site directed nuclease, if a nucleic acid template was added to guide homology directed repair (otherwise known as SDN-2 and SDN-3 techniques).
This means that organisms modified using SDNs will not be GMOs, provided no nucleic acid template is added to guide homology-directed repair (also known as SDN-1 techniques). However, organisms modified by oligonucleotide directed mutagenesis, SDN-2 and SDN-3 techniques will be regulated as GMOs. The table below depicts what organisms will be regulated as GMOs under the amendments.
|Organisms excluded from regulation||
Organisms regulated as GMOs
|natural occurring and induced mutations||
Some of the considerations the Regulator took into account in deciding to exclude organisms modified using SDN-1 techniques from GMO regulation were:
- advice from the Gene Technology Advisory Committee that organisms altered by SDN-1 techniques are unlikely to pose risks that are different to conventional breeding (e.g. natural mutations and induced mutations) which are currently Excluded Organisms on the basis that these changes can occur naturally;
- challenges in enforcing compliance with the regulatory scheme if SDN-1 techniques are not excluded, arising from the difficulty in determining whether organisms have been produced from naturally occurring or induced mutations, or from new gene-editing techniques; and
- the demonstrated potential for new gene editing techniques to produce high performing plant varieties and animals with greater efficiency, effectiveness and economies of scale which will be required to satisfy increasing worldwide demand for food, environmental sustainability and animal welfare.
The Amendments also include certain ribonucleic acid (RNA) interference techniques under Schedule 1A of the Regulations (techniques that are not gene technology) for the purpose of the definition of GMO. Specifically, the amendments provide that techniques involving applying RNA to an organism to temporarily induce RNA interference are not gene technology, provided that:
- the RNA cannot be translated into a polypeptide;
- the organism’s genome sequence cannot be altered as a result; and
- an infectious agent cannot be produced.
How this affects food and agribusiness
The amendments will have wide ranging benefits for agricultural research in Australia, allowing animal and plant breeders to utilise new available gene editing technology to develop and bring to market improved varieties at a quicker pace and at a lower cost than traditional breeding methods. The amendments create clarity in the law removing the regulatory risk of investing in new gene edited varieties. This will be a welcomed development for breeders looking to commercialise SDN-1 gene edited varieties, or looking to incorporate such techniques into their breeding programs for the Australian market. These amendments will also ensure that Australian farmers have access to high performing varieties and remain internationally competitive with countries where such techniques are not regulated.
Food Standards Australia New Zealand (FSANZ) is currently reviewing how the Food Standards Code applies to food derived using new breeding techniques, which they define as those new approaches in plant and animal breeding that were not in use when Standard 1.5.2 (food produced using gene technology) was first developed nearly 20 years ago. We wait to see how food produced from gene-edited varieties will be regulated under the Food Standards Code, in particular whether such foods will be excluded from pre-market assessment and approval, and whether such foods will be subject to genetically modified (GM) labelling. FSANZ expects to release its final report on the review this year.
How this affects life sciences
While the application of gene editing techniques to solving human health problems are not nearly as close to commercialisation as in agriculture, the amendments will open up new opportunities in the medicinal research space, giving health and medical researches confidence that they are meeting regulatory requirements in their research and application.
In particular, the application of gene editing techniques have been identified to have potential in the treatment of cancer and HIV.
The amendments to the Regulations will commence from 8 October 2019, and until then the current Regulations continue to apply. We will be watching closely to see how the new amendments play out in practice, and will continue to follow the FSANZ review on how the Food Standards Code will apply to food derived from new breeding techniques. Please contact us should you have any questions or require further information on the amendments.
The amendments and Explanatory Statement can be found at the following links:
- Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 (Cth)
- Explanatory Statement to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 (Cth)
With thanks to Alanna Rennie, associate, for drafting this article.